Terms and Conditions

1. Acceptance of Terms

By accessing and using the services provided by Quantime World Pvt. Ltd., Quantime World INC., and Quantime PTE Ltd. (collectively "Quantime," "we," "us," or "our"), you agree to be bound by these Terms and Conditions. If you do not agree to these terms, please do not use our pharmaceutical clinical logistics services.

2. Services Description

Quantime provides comprehensive pharmaceutical clinical logistics services including but not limited to:

• Drug storage and distribution
• Packaging and labeling services
• Home healthcare logistics
• Bio-samples logistics and export
• Clinical trial management
• Patient travel coordination
• Document archival services
• Comparator procurement
• IRT (Interactive Response Technology) services
• Project management
• Return and destruction services

3. Client Responsibilities

3.1 Compliance Requirements

Clients are responsible for ensuring compliance with all applicable laws, regulations, and industry standards including but not limited to:

• FDA regulations and guidelines
• Good Clinical Practice (GCP) standards
• Good Manufacturing Practice (GMP) requirements
• International Council for Harmonisation (ICH) guidelines
• Local regulatory requirements in all jurisdictions

3.2 Documentation and Information

Clients must provide accurate, complete, and timely information including:

• Clinical trial protocols and amendments
• Regulatory approvals and documentation
• Product specifications and handling requirements
• Patient enrollment data and demographics
• Safety and adverse event reporting requirements

4. Service Level Agreements

Quantime commits to providing services in accordance with agreed service level agreements (SLAs) including:

• Delivery Timeframes: As specified in individual service agreements
• Quality Standards: Compliance with pharmaceutical industry standards
• Temperature Control: Maintenance of cold chain requirements
• Documentation: Complete audit trails and regulatory documentation
• Communication: Regular status updates and reporting

5. Intellectual Property Rights

All intellectual property rights in our services, methodologies, and proprietary systems remain the exclusive property of Quantime. Clients retain ownership of their clinical trial data, protocols, and proprietary information. Both parties agree to maintain confidentiality of each other's proprietary information.

6. Data Protection and Privacy

Quantime is committed to protecting personal and clinical data in accordance with applicable data protection laws including GDPR, HIPAA, and local privacy regulations. We implement appropriate technical and organizational measures to ensure data security and confidentiality.

7. Liability and Indemnification

7.1 Limitation of Liability

To the maximum extent permitted by law, Quantime's liability for any claims arising from our services shall not exceed the total fees paid by the client for the specific service giving rise to the claim in the twelve (12) months preceding the claim.

7.2 Indemnification

Clients agree to indemnify and hold harmless Quantime from any claims, damages, or expenses arising from:

• Client's breach of these terms and conditions
• Client's failure to comply with applicable regulations
• Client's provision of inaccurate or incomplete information
• Client's unauthorized use of our services

8. Payment Terms

Payment terms are as specified in individual service agreements. Generally:

• Invoices are due within 30 days of receipt
• Late payments may incur interest charges
• Services may be suspended for non-payment
• All fees are exclusive of applicable taxes

9. Termination

Either party may terminate service agreements with written notice as specified in individual contracts. Upon termination:

• All outstanding fees become immediately due
• Confidential information must be returned or destroyed
• Data transfer assistance will be provided as agreed
• Ongoing obligations for data retention continue

10. Force Majeure

Neither party shall be liable for delays or failures in performance due to circumstances beyond their reasonable control, including but not limited to natural disasters, government actions, pandemics, regulatory changes, or other force majeure events.

11. Regulatory Compliance

Quantime maintains compliance with all applicable pharmaceutical and logistics regulations including:

• FDA 21 CFR Part 11 (Electronic Records)
• Good Distribution Practice (GDP) guidelines
• International Air Transport Association (IATA) regulations
• Customs and import/export requirements
• Environmental and safety regulations

12. Dispute Resolution

Any disputes arising from these terms or our services shall be resolved through:

• Good faith negotiations between the parties
• Mediation if negotiations fail
• Binding arbitration as a last resort
• Jurisdiction as specified in individual agreements

13. Amendments

Quantime reserves the right to modify these Terms and Conditions at any time. Material changes will be communicated to clients with reasonable notice. Continued use of our services after such changes constitutes acceptance of the modified terms.

14. Governing Law

These Terms and Conditions are governed by the laws of the jurisdiction specified in individual service agreements. For general inquiries, the laws of India shall apply.

15. Contact Information

For questions regarding these Terms and Conditions or our services, please contact us: